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Report for Clinical Trial NCT02930954

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Combination of Gefitinib With Chemotherapy or Anti-angiogenesis as 1st Line Treatment in Advanced NSCLC Patients Detected With Bim Deletion or Low EGFR Activating Mutation Abundance

This is a single arm phase II clinical trial, which aims to evaluate the effectiveness of combination of gefitinib and doublet chemotherapy or antiangiogenesis in advanced non-small cell lung cancer patients with EGFR activating mutation, accompanied with Bim deletion or low activating EGFR mutation abundance.

NCT02930954 Non-small-cell Non-small-cell Lung Cancer
MeSH:Carcinoma, Non-Small-Cell Lu Carcinoma, Non-Small-Cell Lung
HPO:Non-small cell lung carcinoma

3 Interventions

Name: Gefitinib

Description: Patients received Gefitinib 250mg Qd orally until disease progression, intolerable toxicity or death.
Type: Drug
Group Labels: 3

Gefitinib combined with antiangiogenesis Gefitinib combined with chemotherapy Gefitinib single agent

Name: pemetrexed or gemcitabine plus carboplatin,

Description: doublet chemotherapy with pemetrexed or gemcitabine plus carboplatin per 3 weeks
Type: Drug
Group Labels: 1

Gefitinib combined with chemotherapy

Name: bevacizumab

Description: bevacizumab 7.5mg/kg intravenously per 3 weeks
Type: Drug
Group Labels: 1

Gefitinib combined with antiangiogenesis


Primary Outcomes

Description: From start of anti-cancer therapy untill progression or death

Measure: Progression free survival

Time: 8 weeks

Secondary Outcomes

Description: evaluated in the 36th since treatment begain

Measure: overall survival

Time: 36 months

Description: toxicities related to anti-cancer therapy

Measure: side effect

Time: 8 weeks

Description: evaluated since treatment began

Measure: quality of life

Time: 24 months

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 L858R

Inclusion Criteria: - Histologically documented, locally advanced or recurrent (stage IIIb and not amenable to combined modality treatment) or metastatic (stage IV) non-small cell lung cancer, anti-cancer treatment naiive - EGFR exon 19 deletion or exon 21 L858R. --- L858R ---

- Bim deletion by realtime PCR, or low abundance for EGFR mutation, for 19Del less than 4.9%, for L858R less than 9.5%. --- L858R ---

- Unhealed bone fracture or wound for long time Inclusion Criteria: - Histologically documented, locally advanced or recurrent (stage IIIb and not amenable to combined modality treatment) or metastatic (stage IV) non-small cell lung cancer, anti-cancer treatment naiive - EGFR exon 19 deletion or exon 21 L858R. --- L858R ---



HPO Nodes


HPO: